Application 208249

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 500MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208249-001AZITHROMYCINAZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208249-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253f01610625f2…
2019-09-15 20:21 UTC2019-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208249-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208249-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208249-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208249-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208249-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208249-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208249-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208249-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208249-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208249-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208249-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208249-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208249-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208249-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208249-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208249-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208249-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208249-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208249-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208249-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208249-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208249-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208249-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208249-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208249-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208249-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208249-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208249-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208249-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208249-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208249-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208249-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208249-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208249-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208249-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208249-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208249-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208249-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208249-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208249-001AB1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.7711e846-0bb3-486c-8511-f445e264cd982026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
ndc (product): 70518-3168
AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXa6426d5f-5518-3c69-e053-2995a90af50f2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
ndc (product): 72189-090
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsde5b0c2b-9a7d-46e9-8169-4100442efa9b2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATESportpharm LLC11446677-a3dc-40cb-897d-7a9851b8c89c2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.3b90572c-cc24-49f0-baaf-09022a2f9a002026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAvPAKb635019e-7fd4-7f9e-e053-2a95a90a388c2026-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 50268-076
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEHealth Department, Oklahoma State4747c5d8-4831-c725-e063-6394a90a4fda2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug2fd1f4b5-6c32-3075-e063-6294a90a0d4b2025-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC4196e616-bdd8-9e88-e063-6394a90ac81d2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.41e2163b-af61-4323-8b9c-2d44fc122fd92025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
ndc (product): 51224-122
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLCf1755cf3-bf7f-be40-e053-2a95a90a85362024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
ndc (product): 80425-0220
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPbb97a057-2537-41ae-b50c-a80605039c302024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
ndc (product): 71205-491
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsfcf098d5-dfd5-4a0d-81f7-6afa1a203a272024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsb4c05e22-4a54-4948-abf8-8a479d465d302024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPedecf20d-c681-418b-9c47-02fb32d2b3c02024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4700Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4700Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
51224-122Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
51224-122Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
53002-0474Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-7221Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
55700-896Azithromycin DihydrateAzithromycin DihydrateQuality Care Products, LLCANDACurrent
68071-2775Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmceuticals,Inc.ANDACurrent
68071-2775Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmceuticals,Inc.ANDACurrent
68788-8311Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
71205-491Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
72189-090AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72189-090AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
80425-0220Azithromycin DihydrateAzithromycin DihydrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent